Iontophoresis is a well-known technique to introduce ions, electrons, or energy into the body, or to change or create an electric potential, or electrochemical gradients, using electrical current, or to transport ions across a membrane or into a tissue. It is a non-invasive technique that has a number of applications, including transdermal drug delivery to a pre-selected current delivery area, diagnosis of cystic fibrosis and treatment of excessive sweating, also known as hyperhidrosis, on a pre-selected current delivery area. Commercially available iontophoresis methods, devices and systems (that use water baths to conduct electricity to the body or body parts, e.g., the MD-2 Galvanic Iontophoresis Machine from RA Fischer, Calif.) can be inconvenient to use, for example, because they limit mobility during electrical current delivery, hence requiring a dedicated time commitment, and because they are messy to set up, may not ensure effective delivery to the entire pre-selected current delivery area, and/or can be uncomfortable for the user, for example because their use may induce bothersome tingling sensations, feeling of pins and needles, muscle tightening, erythema or mild or severe burns.
Developments aimed at making iontophoresis more convenient (e.g., those described in U.S. Pat. Nos. 8,150,525 and 7,643,874, the entirety of each which are hereby incorporated by reference herein) have not been commercialized, particularly for the purpose of treating hyperhidrosis. A key problem with these and other developments is that they do not provide effective ways to optimally conform to the pre-selected current delivery area. In particular, conductive garments make poor or intermittent contact with the body or body part, and such contact may lead to painful sensations and hence inconvenience. Poor contact or incomplete coverage of the pre-selected current delivery area may also lead to incomplete outcomes. For example, these technologies do not describe ways to cover a sufficient area of the sweat glands that sweat excessively on the body or targeted body part to adequately treat hyperhidrosis (excessive sweating) using electrical current, for example the sides of the fingers for palmar hyperhidrosis, and the sides of the feet for plantar hyperhidrosis. Additionally, these technologies do not describe ways to minimally or not treat parts that do not require management or treatment, for example the arms and knuckles in the case of palmar hyperhidrosis. These technologies also suffer from problems with manufacturability. For example, the garment described in U.S. Pat. No. 8,150,525 would be difficult to manufacture with simple techniques such as die-cutting tools.
Particularly for the management of hidrosis or treatment of hyperhidrosis the lack of a better solution presents a significant unmet clinical need, as no good management or treatment options exist for this population. Hyperhidrosis is caused by overactivity of the sympathetic nervous system that results in a dramatically increased sweat production, far beyond what is required for thermal regulation. People who are not familiar with the condition may not appreciate that hyperhidrosis is the dermatologic condition with the most dramatic impact on quality of life, worse than dermatitis, eczema and psoriasis. 75% of sufferers report that the condition affects their emotional health and the prevalence of depression is tripled in this population. The condition can be particularly debilitating during times in life where social interactions are crucially important. The youngest sufferers get bullied at school when required to hold hands, or are embarrassed when they hand in to their teacher paperwork soaked by perspiration. The condition is also particularly debilitating for adolescents: it affects them emotionally, for example feeling embarrassed when holding hands with someone. Sweaty hands also add pressure during job interviews, with more than 50% of adult patients reporting that the condition has negatively affected them in their professional career. Hidrosis (sweating) that does not reach the medical level of severity may be similarly bothersome to some individuals.
Current treatment options for hyperhidrosis each have at least one major drawback. Antiperspirants are prescribed as first-line treatment, but they are typically ineffective. Botulinum toxin injections can be used, but they are painful and expensive. Systemic medications, such as anticholinergics, are greatly limited by their adverse effects. Sympathetic (thoracic) surgery is an effective but invasive treatment that carries a significant risk of developing compensatory sweating in other body areas such as the chest and back. For the management of hidrosis any of these options would be cumbersome, invasive or expensive.
Thus, there remains a considerable need for methods, devices and systems to deliver electrical current to the body, skin, membrane or other tissue, that are convenient in use, that ensure effective delivery to a pre-selected current delivery area, result in minimal discomfort for the user, and/or are easy to manufacture, even at scale.